Why choosing Qualitätsplan?
...because we know how!
How we do it
We come straight to the point. We work:
- customer-oriented
- reliable
- structured
- pragmatic
- self-reliant
- with a short familiarization period
- by making individual offers for each customer’s need
- by having a high internal quality standard
What we do
Testing Laboratory
We do:
- Test planning
- Verification of product requirements
- Safety and performance testing according to applicable standards (e.g.: IEC 60601-1 and its particular standards)
- Reliability testing
- Summary Reports
Technical Documentation
We compile complete Technical Documentation files including for instance:
- Specifications
- Risk Management Files and Analysis
- Usability engineering files
- Verification and Validation Plan and Reports
- Summary Reports
- Conformity Assessments for MDD and MDR
- Post Market Plans (PMS, PMCF...)
Compliance Engineering
We help our customer to develop a compliant medical device. Therefore we compile:
- Complete safety concepts (including, electrical, mechanical and fireprevending concepts)
- Design reviews
- Insulation diagrams etc.
Don't hesitate to contact us!
